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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K170406
Device Name Plato MICROCATH 27B Microcatheter
Applicant
Scientia Vascular, LLC
3487 W. 2100 S., Suite 100
West Valley City,  UT  84119
Applicant Contact David Sabodski
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1200
Classification Product Code
DQO  
Subsequent Product Codes
DQY   KRA  
Date Received02/10/2017
Decision Date 04/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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